The Effect of Tofacitinib in the Treatment of Morphea

Efficacy and side effects of Tofacitinib in the Treatment of Morphea Compared to Methotrexate

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250102064248N1

Enrollment

Registered

2025-02-14

Start date

2025-01-10

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morphea. Localized scleroderma

Interventions

Intervention 1: Intervention group: Patients with Morphea Treated with Tofacitinib at a Dose of 5 mg Every 12 hours, Once oral for 6 Months. Intervention 2: Control group: Patients with Morphea trea

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: over 18 years old Not receiving treatment in the past year Minimum score of 2 in disease severity activity Generalized or plaque type Morphea

Exclusion criteria

Exclusion criteria: Under 18 years old Linear Morphea Lactation or Pregnancy Receiving treatment in the past year Reluctance to participate in the study

Design outcomes

Primary

Measure	Time frame
Patients with skin disease severity above 2. Timepoint: Measuring the Severity of the Disease at the Beginning of theStudy; 3 Months Later and 6 Months Later. Method of measurement: Localaized Scleroderma Review Table Based on Severity/Activity/Destruction.	—

Secondary

Measure	Time frame
Reduction Rate of Local Sclerodermal cutaneous Assesment Tools. Timepoint: Before the Intervention, 3 months Later and 6 Months Later. Method of measurement: Clinical Score Table.;Reduction Rate of LOcal Sclerodermal Atrophy Index. Timepoint: Before the Intervention, 3 months Later and 6 Months Later. Method of measurement: Clinical Score Table.;Reduction Rate of Local Sclerodermal Damage Index. Timepoint: Before the Intervention, 3 months Later and 6 Months Later. Method of measurement: Clinical Score Table.;Changes in the Thickness of the Dermis. Timepoint: Before the Intervention and 6 Months Later. Method of measurement: Sonography.;Changes in the Thickness of the Hypodermis. Timepoint: Before the Intervention and 6 Months Later. Method of measurement: Sonography.;Changes in Elasticity of Dremis. Timepoint: Before the Intervention and 6 Months Later. Method of measurement: Sonography.;Changes in Elasticity of Hypodremis. Timepoint: Before the Intervention and 6 Months Later. Method of measurement: Sonography.	—

Measure

Time frame

Reduction Rate of Local Sclerodermal cutaneous Assesment Tools. Timepoint: Before the Intervention, 3 months Later and 6 Months Later. Method of measurement: Clinical Score Table.;Reduction Rate of LOcal Sclerodermal Atrophy Index. Timepoint: Before the Intervention, 3 months Later and 6 Months Later. Method of measurement: Clinical Score Table.;Reduction Rate of Local Sclerodermal Damage Index. Timepoint: Before the Intervention, 3 months Later and 6 Months Later. Method of measurement: Clinical Score Table.;Changes in the Thickness of the Dermis. Timepoint: Before the Intervention and 6 Months Later. Method of measurement: Sonography.;Changes in the Thickness of the Hypodermis. Timepoint: Before the Intervention and 6 Months Later. Method of measurement: Sonography.;Changes in Elasticity of Dremis. Timepoint: Before the Intervention and 6 Months Later. Method of measurement: Sonography.;Changes in Elasticity of Hypodremis. Timepoint: Before the Intervention and 6 Months Later. Method of measurement: Sonography.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahshid al-Sadat Ansari

Tehran University of Medical Sciences

Ansarim2200@gmail.com+98 21 5288 8282

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026